Comparison of the therapeutic effects of dexamethasone, metoclopramide, ketorolac, and chlorpromazine on clinical symptoms of patients with acute migraine headache: a double blind randomized clinical trial

Objectives: To compare the therapeutic effects of dexamethasone, metoclopramide, ketorolac, and chlorpromazine on clinical symptoms of patients with acute migraine headache. Design: a double blind randomized clinical trial. Setting and conduct: The eligible patients with acute migraine headache who will refer to Sina Hospital during the study period will be enrolled into the trial. Inclusion criteria: Acute migraine headache; severity of pain at least 4 based on Visual Analog Scale. Exclusion criteria: Pregnancy; breastfeeding; hypertension; renal failure; heart disease; respiratory disease; liver failure; seizure; malignancy; infection or inflammation; peptic ulcer; neurological abnormalities; using immunosuppressive drugs; using ergotamine during last 8 hours; using sedative during last 4 hours. Intervention group: (a) metoclopramide 10 mg intravenous infusion during 15 min single dose; (b) dexamethasone 8 mg intravenous infusion during 15 min single dose; (c) ketorolac 30 mg intravenous infusion during 15 min single dose; (d) chlorpromazine 25 mg intravenous infusion during 15 min single dose Primary outcome: severity of headache before intervention and one and 24 hours after intervention using VAS. Secondary outcome: adverse effect of the drugs one and 24 hours after intervention through history taking. Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 4 group. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences